A multi-stage thrombus removal device

Abstract

A multi-stage thrombus removal device comprises: a spiral balloon, the spiral balloon comprises a balloon body and a shaping tube, the spiral diameter of the distal end of the balloon body is larger than that of the proximal end, and the balloon body is tapered as a whole, and the balloon body is a straight cylinder in the straightened state; the shaping tube comprises an inner tube, a spring coil and a developing ring; the part of the shaping tube located in the balloon body is a tapered spiral structure; the inner tube is a nickel-titanium alloy tube, and a TIP head is connected to the distal end; the spring coil is wound on the inner tube, and the distal end of the spring coil is fixedly connected to the distal end of the inner tube; the developing ring is arranged at both ends of the shaping tube located in the balloon body section; the delivery catheter comprises a traction cavity and a filling cavity, and the part of the shaping tube located in the traction cavity is straight; the operating handle comprises a grip, a knob, a filling seat and a guide wire seat; the knob comprises a slider and a spiral groove, the spiral groove is located on the knob, and when the knob is rotated, the slider is driven to move forward and backward through the spiral groove, the inner tube is connected to the slider and extends the operating handle, and the extended part is connected to the guide wire seat.

Description

Technical Field

[0001] The invention patent relates to the field of medical devices, and in particular to a multi-stage thrombus removal device. Background Art

[0002] When the blood flow is slow, the blood vessel wall is damaged, or the blood is in a hypercoagulable state, it is easy to cause thrombosis. In vascular surgery emergencies, a large number of patients seek emergency treatment due to sudden venous thrombosis or arterial embolism. If such patients are not treated in time, once the embolism lasts too long, there is a risk of limb ischemia and amputation or even thrombus detachment leading to pulmonary embolism. Once this happens, it poses a huge threat to people's property and life safety. Currently, the conventional methods for treating acute ischemic stroke include two categories: interventional thrombolysis and mechanical thrombectomy.

[0003] Interventional thrombolysis is a procedure in which a catheter is used to inject a thrombolytic machine into the vicinity of the lesion in the blood vessel where the lesion is located. A high concentration of thrombolytic agent is instantly formed in the local lesion, thereby accelerating the dissolution of the thrombus and increasing the chance of blood vessel recanalization. For large and long thrombi, very large doses of thrombolytic drugs are required to dissolve such large blood clots, but this is prone to complications, has a high risk, and often does not achieve the desired effect. Mechanical thrombectomy includes thrombectomy, laser thrombectomy, capture thrombectomy, and capture net thrombectomy. Thrombectomy is a more thorough thrombectomy, but it causes excessive damage to the blood vessel wall and is very likely to cause various complications. Laser thrombectomy is difficult to operate, and low laser energy is ineffective. Excessive energy damages the blood vessel and is also prone to various complications. Capture thrombectomy is simple to operate and causes little damage to the blood vessel wall, but it often fails to capture the blood clot. Capture net thrombectomy is simple to operate, but it cannot be used in intracranial blood vessels due to its large size.

[0004] The existing Fogarty thrombectomy balloon catheter is a balloon catheter with a closed front end. The balloon is made of latex material and both ends of the balloon can be developed. After the balloon enters the target blood vessel, it is filled and the thrombus in the occluded blood vessel is crushed. The thrombus will be dragged out of the body along with the balloon. However, the diameter of the blood vessel changes. When the thrombus is removed from the proximal end to the distal end, the diameter of the blood vessel changes from large to small, while the diameter of the balloon is fixed. When the balloon is pulled to remove the thrombus, the distal end of the blood vessel is greatly damaged; when the thrombus is removed from the distal end to the proximal end, the thrombus will not be removed cleanly. In addition, the Fogarty thrombectomy balloon catheter is a single balloon, and the thrombus can only be removed once, and sometimes it is often not removed cleanly, and multiple thrombus removals may be required, which causes great damage to the blood vessels.

[0005] When a long, closed thrombus forms in a blood vessel, the guidewire often cannot pass through, and the balloon catheter cannot be delivered to the distal end of the thrombus through the guidewire. When the vascular stenosis caused by the thrombus is severe, the sheath cannot pass through, and the balloon catheter cannot be effectively delivered through the sheath.

[0006] Therefore, a thrombectomy balloon catheter that can adapt to changes in blood vessel diameter, achieve multiple clearance effects in a single thrombectomy, and can pass through narrow blood vessel channels is currently needed in clinical practice. Summary of the invention

[0007] The purpose of the present invention is to overcome the above disadvantages and provide a multi-stage thrombus removal device.

[0008] The technical solution adopted by the present invention is as follows:

[0009] A multi-stage thrombus removal device, comprising:

[0010] A spiral balloon, comprising a balloon body and a shaping tube, wherein the spiral diameter at the distal end of the balloon body is larger than that at the proximal end, and the balloon body is tapered as a whole; the balloon body is in the shape of a straight cylinder when stretched, and the spiral diameter is 1-5 times the diameter of the balloon body in the straight cylinder state; the shaping tube comprises an inner tube, a spring coil and a developing ring; the portion of the shaping tube located within the balloon body is a tapered spiral structure, the shaping tube within the balloon body is located at the center of the balloon body, and the taper is the same as that of the balloon body; the inner tube is a nickel-titanium alloy tube, and a TIP head is connected to the distal end; the spring coil is wound around the inner tube, and the distal end of the spring coil is fixedly connected to the distal end of the inner tube; the developing ring is arranged at both ends of the shaping tube located within the balloon body; a delivery catheter The delivery catheter includes a traction cavity and a filling cavity, the traction cavity is used to pass the shaping tube, and the part of the shaping tube located in the traction cavity is straight; an operating handle, the operating handle includes a grip, a knob, a filling seat and a guide wire seat; the knob includes a slider and a spiral groove, the spiral groove is located on the knob, and when the knob is rotated, the slider is driven to move back and forth through the spiral groove, the inner tube is connected to the slider and extends out of the operating handle, and the extended part is connected to the guide wire seat; when the knob is rotated, the inner tube pulls the spring coil, and at this time, each layer of the spring coil will be close to each other and tend to be parallel to each other. From the overall perspective, the spring coil will tend to be straight.

[0011] Preferably, the capsule is made of a compliant or semi-compliant material.

[0012] Preferably, the TIP head is conical and is used to guide the spiral balloon.

[0013] Preferably, a wire guide hole is provided on the TIP head.

[0014] Preferably, the distal end of the spring coil and the distal end of the inner tube are connected together by welding. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 A multi-stage thrombus removal device, namely the present invention;

[0016] Figure 2 Side view of the spiral balloon;

[0017] Figure 3 Shaping tube diagram Figure 1 ;

[0018] Figure 4 Shaping tube diagram Figure 2 ;

[0019] Figure 5 Schematic diagram of spring coil;

[0020] Figure 6 The process of removing thrombus using the present invention;

[0021] Figure 7 Another embodiment of a helical balloon. DETAILED DESCRIPTION

[0022] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0023] A multi-stage thrombus removal device, comprising:

[0024] The spiral balloon 100 is a conical spiral structure. The spiral balloon 100 comprises an outer balloon body 120, an inner shaping tube 130, and a TIP head 110 at the head end. The balloon body 120 is a conical spiral structure, the spiral diameter of which gradually decreases from far to near, and the whole is conical, and the tip of the cone is connected to the delivery catheter 200. When the balloon body 120 is straightened, it is a straight cylinder, and the diameter of the entire straight cylinder is the same. The spiral diameter of the balloon body 120 is 1-5 times the diameter of the straight cylinder in the straight state; the balloon body 120 is a compliant and semi-compliant balloon, and has a certain amount of deformation.

[0025] The shaping tube 130 includes an inner tube 133, a spring coil 134 and developing rings 131 and 132. The portion of the shaping tube 130 located inside the capsule 120 is a spiral structure and is tapered as a whole. This portion of the shaping tube 130 is located at the center of the capsule 120, that is, the spiral diameter, the spacing of each spiral layer and the taper of the spiral are the same for both. The inner tube 133 is a nickel-titanium alloy tube with a TIPS head connected to the distal end. The lumen of the inner tube 133 is mainly used to pass a guide wire, so that after the guide wire is in place, the spiral balloon can be delivered to its place along the guide wire. The spring coil is wrapped around the inner tube, and the distal end of the spring coil is fixedly connected to the distal end of the inner tube, while the remaining parts can slide against each other. The developing rings are arranged at both ends of the shaping tube located in the capsule section for developing positioning. When the shaping tube is in a spiral state, there will be a certain gap between each layer of the spring coil, and they will be at a certain angle relative to each other, such as Figure 4 When the inner tube is pulled, the spring coils will be tightened and parallel to each other, and the gap will disappear. At this time, the shaping tube will become straight as a whole. When the inner tube is relaxed, the shaping tube will return to a spiral state.

[0026] The TIP head is provided with an inner hole, which is the same as the shaping tube, for easy insertion of the guide wire. When the blood vessel is severely narrowed due to the thrombus, and it is not appropriate to transport the spiral balloon to the distal end of the thrombus through the sheath, the inner tube 133 is stretched to make the entire spiral balloon change from a spiral shape to a straight shape, so as to pass through the narrow section of the thrombus and facilitate transportation.

[0027] The tapered spiral balloon can reduce damage to blood vessels and increase the number of thrombectomy attempts, making thrombectomy cleaner without damaging blood vessels. When removing the thrombus, since the thrombus removal balloon is often placed close to the heart, the spiral balloon moves from the proximal end to the distal end during thrombus removal. At this time, the blood vessel diameter decreases from large to small. When the spiral balloon is pulled backward, a part of the thrombus is first removed by the spiral balloon segment with a smaller spiral diameter. At this time, the thrombus larger than the diameter of this spiral balloon segment is still there. The thrombus remaining on the blood vessel wall is further removed by the spiral balloon segment with a larger diameter. At this time, if there is still thrombus remaining on the blood vessel wall, the spiral balloon segment with a larger diameter will remove the remaining thrombus, so that the thrombus is removed in segments, avoiding the problem of unclean thrombus removal at a single time. At the same time, since the cross-section of the spiral balloon in the straight state is much smaller than the blood vessel diameter, the blood vessel wall will not be damaged due to the excessive diameter of the spiral balloon during the sampling process, because when the blood vessel lumen is small, the force on the spiral balloon becomes larger. At this time, the spiral balloon is stretched axially to reduce the cross-sectional diameter of the entire spiral balloon, thereby avoiding damage to the blood vessel wall.

[0028] During production, the spring coil 134 is first tightly wound around the outer surface of the inner tube 133, and then molded into the required spiral structure. Then, the distal spring coil 134 and the inner tube 133 are fixed together by welding. The proximal end of the spring coil 134 and the inner tube 133 are free to move, but the spring coil 134 needs to be fixed to the distal end of the delivery catheter 2 to play a fixing role.

[0029] The delivery catheter 200 is a double-lumen structure, which is divided into a traction cavity and a filling cavity. The traction cavity is mainly used to pass the shaping tube 130 so that it can slide smoothly in the cavity. The portion of the shaping tube located in the traction cavity is straight. The filling cavity is mainly used to inject water into the spiral balloon to expand the spiral balloon.

[0030] The operating handle 300 comprises a handle grip 310, a knob 320, a filling seat 330 and a guide wire seat 340; the handle grip 310 is mainly used for holding operation; the knob 320 comprises a slider 321 and a spiral groove 322 on the knob, wherein the slider 321 is fixedly connected to the inner tube 133, and by rotating the knob 320, the slider 321 and the gear 322 are relatively moved, thereby driving the inner tube 133 to move forward or backward, and while the inner tube 133 is fixed to the slider 321, it also passes through the slider and extends the operating handle, and the guide wire seat 340 is connected to the inner tube 133 for inserting a guide wire to guide balloon delivery; the filling seat 330 is mainly used for injecting liquid to fill the balloon, or extracting liquid to release the function of the balloon.

[0031] When in use, the knob 320 is first rotated to stretch the shaping tube 133 backward, thereby tightening and straightening the spring coil 134, so that the entire balloon body 120 becomes flat, which is convenient for delivery. When the thrombus segment is passed and reaches the distal end of the thrombus, the knob 320 is rotated again to restore the spring coil 134 to its original shape, i.e., spiral shape, and the shaping tube 130 also becomes spiral shape, and then the spiral balloon is filled through the filling seat 330.

[0032] In another embodiment, when the guidewire can no longer pass through a blood vessel blocked by a thrombus, the inner tube 133 can be designed as a solid structure, and no guidewire is required during use. After the inner tube 133 is pulled and stretched, the balloon is straightened to directly pierce the thrombus forward, thereby replacing the guidewire.

[0033] In another embodiment, when the diameter of the blood vessel does not change much, the entire spiral balloon is in a spiral shape with a constant diameter, which facilitates cleaner removal of the thrombus. Figure 7 .

[0034] In another embodiment, the delivery catheter 200 is a single-lumen structure, and the inner tube 133 passes through the inner lumen of the delivery catheter 200. In this case, the inner tube 33 and the filling cavity share a tube body. When the balloon is filled, the liquid enters the balloon from the gap between the inner tube 133 and the filling cavity.

[0035] The described embodiments are to be considered in all respects as illustrative only and not restrictive. Therefore, the scope of the present disclosure is indicated by the appended claims rather than by the preceding description. All changes within the equivalent meaning and scope of the claims are included within their scope. The present invention is not limited to the above-described embodiments, which does not mean that the present invention must rely on the above-described embodiments to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent replacement of the raw materials selected by the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the scope of protection and disclosure of the present invention.

Claims

1. A multi-stage thrombus removal device, characterized in that: include: A spiral balloon, the spiral balloon comprising a balloon body and a shaping tube, the spiral diameter of the distal end of the balloon body is larger than the spiral diameter of the proximal end, and the balloon body is tapered as a whole. The balloon body is in a straight cylindrical state, and the spiral diameter is 1-5 times the diameter of the balloon body in the straight cylindrical state; the shaping tube comprises an inner tube, a spring coil and a developing ring; the portion of the shaping tube located in the balloon body is a tapered spiral structure, the shaping tube in the balloon body is located at the center of the balloon body, and the taper is the same as that of the balloon body; the inner tube is a nickel-titanium alloy tube, and a TIP head is connected to the distal end; the spring coil is wound on the inner tube, and the distal end of the spring coil is fixedly connected to the distal end of the inner tube; the developing ring is arranged at both ends of the shaping tube located in the balloon body section; A delivery catheter, the delivery catheter comprising a traction cavity and a filling cavity, the traction cavity is used to pass the shaping tube, and the portion of the shaping tube located in the traction cavity is straight; An operating handle, the operating handle includes a grip, a knob, a filling seat and a guide wire seat; the knob includes a slider and a spiral groove, the spiral groove is located on the knob, when the knob is rotated, the slider is driven to move forward and backward through the spiral groove, the inner tube is connected to the slider and extends out of the operating handle, and the extended part is connected to the guide wire seat; when the knob is rotated, the inner tube pulls the spring coil, at which time each layer of the spring coil will be close to each other and tend to be parallel to each other, and from the overall view, the spring coil will tend to be straight.

2. A multi-stage thrombus removal device according to claim 1, characterized in that: The capsule is made of compliant or semi-compliant material.

3. The multi-stage thrombus removal device according to claim 1, characterized in that: The TIP head is conical and is used to guide the spiral balloon.

4. The multi-stage thrombus removal device according to claim 1, characterized in that: The TIP head is provided with a wire guide hole.

5. The multi-stage thrombus removal device according to claim 1, characterized in that: The distal end of the spring coil is connected to the distal end of the inner tube by welding.

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